CVS pharmacy pulls oral phenylephrine cold medicines from shelves. Will Walgreens and others follow?

Pharmacies are facing numerous challenges as fall progresses—just in time for cold and flu season. The first challenge is a labor one. Pharmacy staff from CVS and Walgreens have already walked off the job in protest of working conditions. Now one of the big chain pharmacies’ bestselling products has been found to be ineffective by an advisory committee to the Food and Drug Administration (FDA), a finding that has prompted CVS to pull it from the shelves. Here’s what you need to know.

What’s happened?

In September, the FDA advisory committee on nonprescription drugs announced the results of its investigation into the effectiveness of oral phenylephrine. Phenylephrine is a medication that is used to treat particular symptoms of colds and the flu, such as a stuffy nose and the feeling of blocked ears and sinuses. The only problem with the medication is that the committee found that the oral version of it isn’t effective. 

So cold medicine isn’t effective against symptoms?

Not exactly. Not all cold medicines are based on oral phenylephrine or only oral phenylephrine. What the committee found was that oral phenylephrine-only medications are ineffective at treating cold and flu symptoms.

What about nasal sprays?

The FDA panel only examined oral phenylephrine medication and found that it is ineffective. The regulatory body said, “Phenylephrine-containing nasal sprays will not be affected by any possible actions taken for phenylephrine in orally administered products.” In other words, the finding had no say on the effectiveness of the nasal spray version of the medication. 

What about oral cold medicines with phenylephrine plus other ingredients?

If a product contains oral phenylephrine plus other medications to treat additional symptoms, the FDA panel says those other medications remain effective. “Consumers should also know that some products only contain phenylephrine,” the agency wrote. “Other products contain phenylephrine and another active ingredient (e.g., acetaminophen or ibuprofen) that treats symptoms other than congestion like headaches or muscle aches, and the presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms.”

So is oral phenylephrine unsafe?

It appears that a recommended dosage is perfectly safe—it’s just ineffective at fighting cold and flu symptoms. As the FDA put it: “neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.”

So why is CVS pulling oral phenylephrine cold meds?

The company seems to be doing it proactively. The FDA hasn’t mandated oral phenylephrine cold meds be pulled from shelves yet. But it’s a good move for the consumer as CVS doesn’t appear to be willing to sell them an ineffective remedy. It should be noted that CVS is only pulling cold medications that have oral phenylephrine as the sole active ingredient.

What about other pharmacy chains?

We reached out to Walgreens and Rite Aid to ask:

Walgreens: A spokesperson for Walgreens said, “We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps.”
Rite Aid: A spokesperson for Rite Aid said the chain plans to continue stocking the products for now: “Rite Aid follows guidance from regulatory agencies, including the FDA, and is committed to providing convenient access to approved products to address our customers’ healthcare needs. Our pharmacists are available to provide guidance to customers on over-the-counter solutions for alleviating symptoms associated with colds and other illnesses.

Could the panel’s finding hurt big chain pharmacies’ bottom lines?

If the FDA mandates pharmacies pull oral phenylephrine products, then yes. The reason is that cold and flu season is upon us and, as CNBC points out, 242 million bottles of drugs containing phenylephrine were sold last year, generating $1.8 billion in sales.

This story has been updated with responses from Walgreens and Rite Aid, and also to clarify that the finding on phenylephrine was made by an advisory committee to the FDA. The FDA has not made a final decision on the ingredient.